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Nov 2016


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FDA's Two New Draft Guidance on Software and Device Changes and the 510(k)

Online Event


Key Take Away:

This webinar will teach you how to use a series of flowcharts to evaluate whether or not a change to a medical device or to software requires a new draft guidance 510(k) submission, based on the type of medical device changes, and the impact on the safety and effectiveness of the device as used by a person.


This webinar is intended to provide an overview of 2 new FDA draft guidance documents that clarify when medical device and software manufacturers must file a 510(k) submission requirement (premarket notification) for changes to an existing device and/or software integrated with a device.

The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company’s decisions are provided.

The critical decision is whether a proposed change to a legally marketed medical device subject to premarket notification requirements is significant enough to require FDA review. This includes any major change or modification to the intended use of the device that could have an impact on patient safety and effectiveness.

FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary. The flowcharts address changes to:

FDA Labeling
Technology, engineering and performance
Technology, engineering, performance and materials for in vitro diagnostic devices
The second FDA guidance addresses proposed changes to software used in conjunction with a medical device. The draft includes modifications made to correct software defects, provide patches or updates to code, and provide enhancements or modifications to functionality. Software manufacturers must determine whether any change or modification could potentially and significantly affect the safety or effectiveness of a device.

The first step recommended by FDA is to conduct a risk assessment of the change, including all potential new risks along with known risks for the device. Again, the FDA provides a flowchart to guide software manufacturers through the process of determining whether a 510(k) Device Modifications must be prepared. FDA also provides examples of changes to software, along with an analysis as to why a new 510(k) premarket notification would or would not be needed.

The FDA notes that while neither of these drafts specifically includes combination products, the general concepts may be helpful in determining whether changes to device constituent parts of combination products need a 510(k).

The guidance documents also do not address 510(k) submission requirements for remanufacturers of existing devices, such as re-processors of single-use devices.

Why Should You Attend:

You should attend this webinar if you have any role in evaluating changes to medical devices, including those to labelling, technology/engineering/performance, and materials.

You will learn what factors should prompt additional testing, and the type of documentation to prepare for FDA Medical Device & Software Guidance, whether a new 510(k) is required or not.

Areas Covered In This Webinar:

Medical Device changes
Software Application changes for software used in conjunction with medical devices
FDA Guidance Documents
FDA Enforcement
New FDA 510(k) submission
Flowcharts for decision-making

Learning Objectives:

Know the key aspects of the two FDA draft guidance documents
Specific recommendations for how to assess the level of risk associated with the product and the change to it
Examples the FDA uses to give guidance on what devices and/or software changes require a 501(k) and what ones do not

Who Will Benefit:

Manufacturing Managers and Analysts
Device and Software Engineers
Compliance and Audit Managers
Information Technology Analysts
Information Technology Developers and Testers
QC/ QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Laboratory Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders/ Subject Matter Experts
Business System/ Application Testers

Speakers Profile:

Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

For more detail please click on this below link:

Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509

Fax: +1-516-300-1584




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